Advance Supply of Emergency Contraception Compared to Routine Postpartum Care in Teens

Phase 4

Completed

• Conditions: Post Partum
• Interventions: Drug: Plan B (Levonorgestrel)

• Registration Number: NCT00433004
• Lead Sponsor: University of Pennsylvania

Brief Summary

This is a pilot randomized controlled trial to assess the effects of advanced supply of emergency contraception versus routine care in a teen postpartum population. The goals are to assess feasibility of recruiting and retaining postpartum teens; to obtain estimates of the prevalence of (use of Plan B, primary contraceptive continuation, unprotected intercourse exposure, and pregnancy rates), in postpartum teens given advanced supply of Plan B; to assess whether or not (lack of use of Plan B, contraceptive method non-continuation, and unprotected intercourse exposure), are surrogate markers for risk of unintended pregnancy.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-08
• Study First Submitted QC: 2007-02-08
• Study First Posted: 2007-02-09
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2017-05-11
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-17
• Last Update Submitted: 2017-08-17
• Results First Posted: 2017-09-15
• Last Update Posted: 2017-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

1. Female
2. English speaking
3. Aged 14-19 at enrollment
4. Immediately postpartum of a live infant
5. Planning to parent the baby
6. Desiring to delay another pregnancy for at least one year
7. General good health
8. Willing and able to follow the study protocol

Exclusion Criteria

1. Allergy to levonorgestrel
2. Current substance abuse
3. Plans for relocation outside of Philadelphia

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Plan B (Levonorgestrel)	Advance supply of emergency contraception is given

Primary Outcome Measures

Name	Time	Method
PLAN B USE	1 year
ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR.	1 year
PREGNANCY RATES	1 year

Trial Locations

Locations (1)

Hospital of University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States